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ACTIVE NOT RECRUITING Phase 2

The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept

NCT03604406 · View on ClinicalTrials.gov ↗

Study Summary

This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies. Inclusion/exclusion criteria for this sub-study mirror that of the parent VERVE trial with the exception of abatacept therapy being allowed. Preliminary data from the VERVE parent protocol enrolling patients using anti-TNF therapy is encouraging in that few patients experienced adverse events (56 adverse events in 50 participants, out of 140 participants in total) and that 96.2% of these adverse events were considered either mild or moderate. Importantly, there have been no instances of vaccine dissemination or zoster events to date.

Interventions

  • BIOLOGICAL Varicella Zoster Vaccine
  • OTHER Placebo Injection

Study Locations (5)

Idaho

  • St. Luke's Health System — Boise

Minnesota

  • St. Paul Rheumatology — Eagan

New Mexico

  • Jayashree Sinha, MD — Clovis

Oregon

  • Oregon Health & Science University — Portland

Tennessee

  • Arthritis Associates — Hixson

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2014-05-08
Est. Completion 2026-02
Phase Phase 2

Sponsor

Kevin Winthrop

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03604406

The ClinicalTrials.gov registry entry for NCT03604406 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kevin Winthrop, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions — of which Varicella Zoster Vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03604406 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Idaho, Minnesota, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03604406 about?

NCT03604406 is a clinical study titled "The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept". This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patien...

What is the current status of trial NCT03604406?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2014-05-08. Estimated completion is 2026-02.

What conditions does trial NCT03604406 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Herpes Zoster, Inflammatory Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03604406?

The interventions under investigation include: Varicella Zoster Vaccine (BIOLOGICAL), Placebo Injection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03604406?

This trial is sponsored by Kevin Winthrop, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03604406 being conducted?

This trial has 5 study locations across Idaho, Minnesota, New Mexico, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial